State Enforcement Notifications
SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 337(b)) authorizes States to enforce certain sections of the act in their own names, but provides that States must notify FDA before doing so. Section 100.2(d) (21 CFR 100.2 (d)) sets forth the information that a State must provide to FDA in a letter of notification when it intends to take enforcement action under the act against a particular food located in the State. The information required under § 100.2(d) will enable FDA to identify the food against which the State intends to take action and advise the State whether Federal action has been taken against it. With certain narrow exceptions, Federal enforcement action precludes State action under the act.
This is a request for extension by OMB of its approval of the information collection requirements in the following citation:
Describes the information to be in a notification from a State advising FDA of the State's intent to initiate enforcement of certain requirements of the act.
2. Purpose
and Use of the Information Collection
Section 310(b) of the act provides that States must submit notice to FDA before taking action to enforce certain provisions of the food misbranding provisions of the act. This information will be used by the agency in reaching a conclusion as to whether Federal action is being or will be taken against the same product that is under consideration for action by the State.
3. Use
of Improved Information Technology and Burden Reduction
The regulation for State
notices of intended enforcement actions does not specifically
prescribe the use of automated, electronic, mechanical or other
technological techniques or other forms of information technology as
necessary for use by the States. States are free to use whatever
forms of information technology may best assist them in their
development of a notice.
4. Efforts
to Identify Duplication and Use of Similar Information
The notification provisions of
100.2(d) eliminate the possibility that State action against a food
for violation of the Federal law would be duplicated by FDA. Because
the enforcement provisions are limited to labeling provisions of the
act that are enforced by FDA, there is no likelihood of duplication
by other Federal agencies.
5. Impact
on Small Businesses or Other Small Entities
.
The provisions of this
regulation are specific to State governments and are not applicable
to small businesses.
6. Consequences
of Collecting the Information Less Frequently
There
are no consequences to Federal program or policy activities if the
information is not collected or is collected less frequently. Under
section 310(b) of the act, a State's standing to bring an action
under the act is predicated on the State submitting a letter of
notification to FDA. Therefore, if the letter of notification is not
submitted, the State cannot institute an action to enforce a
provision of the act.
7. Special Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this information collection.
In accordance with 5 CFR 1320.8(d), on July 18, 2008 (73 FR 41360), a 60-day notice for public comment was published in the Federal Register. FDA received one comment, which was not responsive to the comment request.
This information collection does not provide for payment or gifts to respondents.
State notifications to FDA under section 310(b) of the act will contain information compiled for law enforcement purposes and may contain trade secrets or confidential commercial or financial information. Accordingly, section 100.2(i) provides that information contained in the required notification will be exempt from public disclosure to the same extent to which such information would be exempt under 21 CFR 20.61, 20.64, and 20.88.
12. Estimates
of Annualized Burden Hours and Costs
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1 |
|||||
21 CFR Section |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours per Response |
Total Hours |
100.2(d) |
1 |
1 |
1 |
10 |
10 |
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated reporting burden for § 100.2(d) is minimal because enforcement notifications are seldom used by States. During the last 3 years, FDA has not received any new enforcement notifications; therefore, the agency estimates that one or fewer notifications will be submitted annually. Although FDA has not received any new enforcement notifications in the last three years, it believes these information collection provisions should be extended to provide for the potential future need of a State government to submit enforcement notifications informing FDA when it intends to take enforcement action under the act against a particular food located in the State.
Estimated Annualized Cost for the Burden Hours
FDA estimates the annualized burden hour cost to a respondent for completion and submission of an enforcement notification to be approximately $668. FDA estimates that a state administrator’s average wage to be that of a Federal government employee at the GS-12/Step-1 rate for the Washington-Baltimore locality pay area for the year 2008, which makes the annual wage cost for completion and submission approximately $334 (10 hours x $33.43 per hour). To account for overhead, this cost is increased by 100 percent, making the total estimated burden hour cost to the respondent $668.
13. Estimates of Other
Total Annual Cost Burden to Respondents and Record Keepers
There
are no capital costs or operating and maintenance costs associated
with this collection.
14. Annualized
Cost to Federal
Government
FDA
estimates that the annualized cost to the Federal government for the
review and evaluation of enforcement notifications submitted under
section 100.2(d) is approximately $3,180. This is based on
the assumption that review and evaluation by a Federal employee will
take about 40 hours per notification at $39.75 per hour (the
GS-13/Step-1 salary rate for the Washington-Baltimore locality pay
area for the year 2008). Thus, the wage cost to the Federal
government for review and evaluation of notifications would be $1,590
(40 hours x $ 39.75 per hour). To account for overhead, this cost is
increased by 100 percent, making the total estimated cost to the
federal government $3,180.
15. Explanation for Program
Changes or Adjustments
There is no change in the burden estimate.
16. Plans for Tabulation and Publication and Project Time Schedule
The
information obtained from this data collection will not be
published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
No approval is requested.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
N/A
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